Details for New Drug Application (NDA): 088617
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The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 088617
Tradename: | HYDROXYZINE HYDROCHLORIDE |
Applicant: | Pliva |
Ingredient: | hydroxyzine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 088617
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 088617
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 088617 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5060 | 0093-5060-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-5060-01) |
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 088617 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5060 | 0093-5060-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-5060-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 10, 1986 | TE: | AB | RLD: | Yes |
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